Content management and enterprise content compliance sound like corporate IT topics, but the operations team needs to be at least as well informed about them as its IT counterparts.
"The evolution beyond ECM to comprehensive ECC solutions enables organizations to manage and automate complex regulatory compliance and content exchange needs, both across the organization and throughout the product life cycle," writes Alan Louie, research director at IDC Health Insights, in a newly released report. Louie conducted the research for Virtify, which makes the report available via its website.
A drugmaker's ability to identify and reuse key data elements has become critical in creating additional and accurate regulatory documents concerning operations procedures, quality, validation and manufacturing, the report says.
Virtify, a maker of ECC software for life sciences, sees "vast inefficiencies" with regulatory information management and estimates that a quarter of product cost lies in document and compliance issues. Though the proportion of that information related to manufacturing varies from product to product, it's always significant. And the manufacturing data becomes a post-approval lightning rod for regulators when things go awry. ECC solutions now let drugmakers "parallel process," says Virtify, and author regulatory product content while automating the expanding regulatory compliance requirements.
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- check out Virtify's release